Boehringer Ingelheim Release: ECC 2015: GIOTRIF (Afatinib) Demonstrates Superior Survival Compared To Tarceva (Erlotinib) For Patients With Previously Treated Advanced Squamous Cell Carcinoma Of The Lung, Independent Of EGFR Mutation Status

INGELHEIM, Germany--(BUSINESS WIRE)--Boehringer Ingelheim today announced at the European Cancer Congress (ECC) in Vienna, Austria, new data from the Phase III LUX-Lung 8 trial which further highlights the benefits of afatinib^* compared to erlotinib for the treatment of patients with previously treated advanced SCC of the lung. Data from the trial showed that treatment with afatinib resulted in superior progression-free survival (PFS) and superior overall survival (OS) compared to erlotinib in this patient population. These improved survival outcomes observed with afatinib were not driven by the presence of EGFR mutations, according to a new analysis presented at ECC. Furthermore, a higher number of patients treated with afatinib in the LUX-Lung 8 trial reported improvements in overall health and quality of life, as well as improvements in some lung cancer-related symptoms, compared to those treated with erlotinib.

LUX-Lung 8 clinical trial investigator Glen D. Goss, M.D., Director of Clinical and Translational Research, The Ottawa Hospital Cancer Center, University of Ottawa, Canada, commented: “These latest data not only demonstrate benefits of afatinib compared to erlotinib for patients with SCC of the lung, but also suggest that afatinib is an effective treatment option for a broad group of patients and not just those whose tumours harbour EGFR mutations. We know that dysregulation of ErbB receptors plays a role in the underlying mechanisms of SCC of the lung and the fact that afatinib targets this family of receptors rather than only EGFR, may explain why it offered additional benefits for this patient population.”

Afatinib is an oral, once daily targeted treatment which works by irreversibly blocking the ErbB family of receptors. Unlike other targeted treatments such as erlotinib which are reversible and specifically target EGFR (ErbB1), afatinib aims to provide a sustained, selective and complete ErbB Family Blockade. The Phase III LUX-Lung 8 trial compared afatinib to erlotinib in patients with advanced SCC of the lung progressing after treatment with first-line platinum-based chemotherapy. Data from the trial showed that treatment with afatinib resulted in superior PFS, reducing the risk of cancer progression by 19%, and superior OS, reducing the risk of death by 19% compared to erlotinib in this patient population. The PFS and OS advantages observed with afatinib compared to erlotinib were independent of the EGFR mutation status of the tumours analysed from this trial.

Further data presented at ECC confirm the efficacy of afatinib observed in the LUX-Lung 8 trial was associated with improvements in patient reported outcomes. More patients had improved overall health-related quality of life (36% vs 28%, p=0·041), cough (43% vs 35%, p=0·029) and dyspnoea (51% vs 44%, p=0·061) with afatinib than with erlotinib. The rate of severe adverse events in the LUX-Lung 8 trial was similar between the two treatment arms with differences observed in the incidence of certain side effects. A higher incidence of severe diarrhoea and stomatitis (mouth sores) was observed with afatinib compared to erlotinib (grade 3 diarrhoea: 10% vs 2%; grade 3 stomatitis: 4% vs 0%), while a higher incidence of severe rash/acne was reported with erlotinib compared to afatinib (grade 3 rash/acne: 10% vs 6%). Diarrhoea occurring in patients treated with afatinib was manageable.

Dr. Mehdi Shahidi, Medical Head, Solid Tumour Oncology, Boehringer Ingelheim commented: “We are pleased to present these data at ECC 2015 which confirm that the advantages of afatinib, compared to erlotinib, are not limited to patients with squamous cell lung cancer whose tumours expressed EGFR mutations, which are rare in this disease. The LUX-Lung 8 trial shows that treatment with afatinib versus erlotinib not only leads to improved survival outcomes but also offered patients an improved quality of life. Afatinib is under review by both the FDA and EMA for the treatment of SCC of the lung and we look forward to working with regulatory authorities in the hope of making this much needed new treatment option available to patients.”

Afatinib is currently approved in more than 60 countries for the first-line treatment of specific types of EGFR mutation-positive non-small cell lung cancer (NSCLC) (under brand names: GIOTRIF^® / GILOTRIF^®). Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have recently accepted filing applications for afatinib for the treatment of patients with advanced SCC of the lung progressing after treatment with first-line chemotherapy, based on the positive PFS and OS data from the LUX-Lung 8 trial. Afatinib has also been granted orphan drug designation by the FDA – a status given to a product intended for the treatment of a rare disease or condition.

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^*Afatinib is approved in a number of markets, including the EU, Japan, Taiwan and Canada under the brand name GIOTRIF^® and in the US under the brand name GILOTRIF^® for use in patients with specific types of EGFR mutation-positive NSCLC. Registration conditions differ internationally, please refer to locally approved prescribing information. Afatinib is under regulatory review by health authorities in other countries worldwide. Afatinib is not approved in other indications.

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